ClinicalTrials.gg
RecruitingNCT07802717Updated Sep 21, 2026

A Phase 1 Dose-escalation and Expansion Study of In Vivo BCMA-CAR T Cell Therapy (VV169) in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1 interventional study of VV169 in Multiple Myeloma Refractory and Multiple Myeloma in Relapse, sponsored by Vyriad, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Vyriad, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 2,168 studies in Multiple Myeloma with a site in United States — 276 open to participants now, 503 under way, 66 of them phase 3. Multiple Myeloma · United States.

Planned enrollment
865th of 1,901
40 · median 36
Started
2026
with 75 others
Phase 1
559 of 2,168
65 open now
Primary completion
2027-08
later than 258 of 499 live
Registered
2,164th of 2,168
by date

Among the 2,168 studies in Multiple Myeloma with a site in United States, this one is the 865th largest by planned enrollment of the 1,901 interventional ones that give a count, is one of 76 that started in 2026, is one of 559 in phase 1, reaches primary completion later than 258 of the 499 other live ones, and was the 2,164th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 772 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

276 of the 2,168 studies in Multiple Myeloma with a site in United States are open now. Recruiting first, the newest first:

270 more — sign in →

All 276 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,168 studies in Multiple Myeloma with a site in United States, or all of them as a file.
02

Study summary

A Phase 1, first in human, study to evaluate the safety and the effects of in vivo BCMA-CAR T cell therapy (VV169) in patients with Multiple Myeloma that has been previously treated and has come back, or does not respond to standard treatments. Eligible patients will receive VV169, a T-cell targeted lentiviral vector, via infusion. Patients will be monitored for safety and tolerability for up to 2 years, until progressive disease or start of next treatment, whichever is earlier.

Read the detailed description

Eligible patients will be recruited into either the dose escalation phase or dose expansion phase. Eligible patients will be adults who have received prior therapy, or are ineligible for, or did not tolerate standard approved treatment and have no available therapies open to them are eligible.

Additional patients will be recruited in the expansion phase once an optimal dose has been identified. In the expansion phase, T cell engagers therapies and anti-BCMA ADC > 6 months prior, and CAR-T therapy received > 9 months prior to study enrollment will be permitted.

03

Conditions studied

  • Multiple Myeloma Refractory
  • Multiple Myeloma in Relapse

Browse trials for

Keywords

  • CAR-T
  • BCMA
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able and willing to sign the form and comply with the protocol and the restrictions and assessments therein.
  2. ≥ 18 years of age.
  3. Active multiple myeloma with at least 3 , OR ineligible for or did not tolerate standard approved treatment and have no available therapies open to them.

    1. For Dose Escalation Phase: No prior T-cell engager therapies. No prior BCMA targeting antibody-drug conjugate (ADC) therapy. CAR-T therapy received ≥2 years prior to study enrollment is permitted.
    2. For Expansion Phase: T cell engagers therapies and anti-BCMA ADC > 6 months prior, and CAR-T therapy received > 9 months prior to study enrollment is permitted.
  4. as defined by .
  5. Performance Status (PS) 0 or 1.
  6. ≥12 weeks.
  7. For those who received prior stem cell transplant, they must be at least 100 days post-transplant, prior to registration and have recovered from side-effects of stem cell transplant.
  8. For those who received prior allogeneic stem cell transplant or donor lymphocyte infusion, they must be at least 100 days post-transplant prior to registration with no signs of acute or chronic .

Exclusion criteria

Exclusion Criteria:

  1. Has monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis. Has Waldenstrom macroglobulinemia, primary amyloid light chains (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin abnormalities (POEMS) syndrome. Patients with secondary plasma cell leukemia or extramedullary myeloma disease are permitted.
  2. Failed to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.

    EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment.

  3. Any of the following because this study involves an integrating lentiviral vector.

    • Pregnant
    • Nursing
    • Women of (and persons able to father a child) who are unwilling to employ adequate
  4. Known to VV169 or any of its .
  5. Has active (untreated or ) CNS involvement of multiple myeloma.
  6. Major surgery ≤ 28 days prior to registration.
  7. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  8. Acute DVT or pulmonary embolism diagnosed within 3 months of registration.
  9. patients and patients known to be positive (current and previous, as HIV antiretroviral therapy is expected to interfere with the lentiviral delivery mechanism of VV169).
  10. Has significant and symptomatic cardiovascular disease (such as congestive heart failure class III or higher, myocardial infarction, cerebrovascular disease, unstable angina, unstable arrhythmia) within the 3 months prior to study drug.
  11. Has another malignant disease requiring treatment, with the exception of curatively treated in-situ or Stage I or malignancies with very low potential for recurrence or progression.
  12. Known active central nervous system (CNS) and/or carcinomatous meningitis.
  13. Known active infection with or , defined by a detectable viral load. Note: Testing is not required for eligibility.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Active relapsed or refractory multiple myeloma with prior lines of treatment

    Dose Escalation

    Biological: VV169

  • Experimental
    Active relapsed or refractory multiple myeloma with no prior lines of treatment

    Dose Expansion

    Biological: VV169

Interventions

  • BiologicalVV169

    T-cell Targeted (CD3- targeted lentiviral vector)

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of VV169 and determine the maximum tolerated dose

    Assess incidence, type and severity of AEs, SAEs, DLTs, and clinically relevant laboratory abnormalities.

    Time frame: 2 years

  2. Determine the recommended phase 2 dose of VV169

    Incidence of DLTs and SAEs per dose level in dose escalation phase.

    Time frame: 28 days post last patient last dose in the Dose Escalation phase.

Secondary outcomes

  1. Anti-tumor activity of the in vivo generated BCMA+ CAR-T cells

    Objective Response Rate

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Aug 2027, 11 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 11 months is below that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 3, 2026
StartActual
Sep 8, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2029
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07802717
Lead sponsor
Vyriad, Inc.
Collaborators
Mayo Clinic
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Sep 8, 2026
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Sep 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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